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THERAPEUTIC GOODS AMENDMENT ACT 2000 NO. 12, 2000 - SCHEDULE 1

- Amendment of the Therapeutic Goods Act 1989

1 Subsection 3(1) (definition of conformity assessment body )

Omit "Mutual Recognition Agreement", substitute "EC Mutual Recognition Agreement or the EFTA Mutual Recognition Agreement".

2 Subsection 3(1) (definition of conformity assessment certificate )

Omit "Mutual Recognition Agreement", substitute "EC Mutual Recognition Agreement or the EFTA Mutual Recognition Agreement".

3 Subsection 3(1)

Insert:

EC Mutual Recognition Agreement means the Agreement on Mutual Recognition in relation to Conformity Assessment, Certificates and Markings between Australia and the European Community, as in force from time to time.

4 Subsection 3(1)

Insert:

EFTA Mutual Recognition Agreement means the Agreement on Mutual Recognition in relation to Conformity Assessment, Certificates and Markings between Australia and the European Free Trade Association, as in force from time to time.

5 Subsection 3(1)

Insert:

member of EFTA means a country declared by the Minister under section 3A to be a member of the European Free Trade Association.

6 Subsection 3(1) (definition of Mutual Recognition Agreement )

Repeal the definition.

7 Subsection 3A(1)

Repeal the subsection, substitute:

(1)
The Minister may declare, in writing, that a country specified in the declaration is a member of:

(a)
the European Community; or

(b)
the European Free Trade Association.

8 Subparagraph 25(2)(a)(i)

After "European Community", insert "or a member of EFTA".

9 Subparagraph 26(2)(a)(i)

After "European Community", insert "or a member of EFTA".

10 Subparagraph 26A(4)(a)(i)

After "European Community", insert "or a member of EFTA".

11 Subsection 61(1) (definition of therapeutic goods information )

Omit "Mutual Recognition Agreement", substitute "EC Mutual Recognition Agreement or the EFTA Mutual Recognition Agreement".


(201/99)
[ Minister's second reading speech made in—
House of Representatives on 25 November 1999
Senate on 6 March 2000 ]



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